Efficacy of Nursing Orientation to Reduce the Anxiety of Patients Undergoing Bed Bath

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Juliana de Lima Lopes, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01724762
First received: November 6, 2012
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

This study's general objective was to evaluate the efficacy of nursing orientation to reduce the anxiety of patients with acute coronary syndrome undergoing bed bath. The specific objectives included: the development and validation of an informative manual concerning bed bath; correlation of physiological variables (systolic and diastolic blood pressure and heart and respiratory rate) with the patients' state anxiety; correlation of antecedent variables (age, gender, cardiovascular risk factor, use of beta blockers, trait anxiety, depression, prior hospitalization, prior experience with bed baths, the patients' preference for a female or male professional to perform the bath, pain, fear, and embarrassment) with the patients' state anxiety.


Condition Intervention
Acute Coronary Syndrome
Other: Nursing Orientation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of the Efficacy of Nursing Orientation to Reduce the Anxiety of Patients With Acute Coronary Syndrome Undergoing Bed Bath

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • STAI-state [ Time Frame: Participants were followed for the duration of hospital stay, an average of 2 weeks ] [ Designated as safety issue: No ]
    The STAI-state was applied immediately after informing the patients about the bed bath, immediately after orientation (intervention group) or immediately after the unit's routine information (control group), and immediately after the bath.


Enrollment: 120
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nursing orientation
Patients who received nursing orientation and read the informative manual concerning bed bath
Other: Nursing Orientation
  • Control group: patients who did not read the informative manual concerning bed bath and received only the unit's routine information
  • Intervention group: patients who received nursing orientation and read the informative manual concerning bed bath

Detailed Description:

Patients with acute coronary syndrome present many physiological and psychological changes, especially anxiety, which can be more intense when the patient expects or experiences certain procedures, such as bed bath. The association of anxiety and acute myocardial infarction has shown negative impact on the prognosis of these patients. The anxiety causes activation of the sympathetic nervous system by increasing cardiac contractility, blood pressure, heart rate and oxygen consumption, worsening disease progression. Thus, minimizing the effects of patients' anxiety in the face of various nursing procedures is essential to quality care. The anxiety can be reduced using medications and/or nursing orientation.

This study was conducted in the Coronary Care Units, Brazilian Heart Institute. The study was divided into two phases. The first comprised the development and validation of an informative manual by nurses and patients. The manual was developed by the researchers and then submitted to validation by five nursing professors from the field of nursing fundamentals and five nurses with experience in coronary care units. The Delphi Technique was used to validate the manual in this phase. After validation by nurses, the manual was validated by 35 patients hospitalized in the coronary care unit who experienced bed bath at least once. A score above 4 should be achieved for the manual to be considered comprehensible and validated by patients. The statistical analysis at this phase was performed through the Wilcoxon rank-sum test and percentage of score 5 with its confidence interval. The study's second phase comprised assessment of the efficacy of nursing orientation to reduce the anxiety of patients with acute coronary syndrome undergoing bed baths. The sample population was composed of 120 patients with acute coronary syndrome hospitalized in coronary care units divided into two groups: control group (patients who did not read the informative manual concerning bed bath and received only the unit's routine information) and the intervention group (patients who received nursing orientation and read the informative manual concerning bed bath). The STAI-state was used to assess anxiety. It was applied immediately after informing the patients about the bed bath, immediately after orientation (intervention group) or immediately after the unit's routine information (control group), and immediately after the bath.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of acute coronary syndrome Killip 1
  • Patients who were undergoing the bed bath for the first time in the current hospitalization
  • Literate and at least 4 years of study
  • Patients with age less than 75 years
  • Patients who agreed to participate

Exclusion Criteria:

  • Patients with vascular diseases or arteriovenous fistulas in the left arm
  • Situations that could influence patients' anxiety and / or vital signs (arrhythmias such as ventricular tachycardia, second or third-degree atrioventricular block ; ischemic pain before, during or after bath; patients with Killip 2, 3 and 4; invasive procedures on the day of data collection, such as catheterization and surgery, and use of benzodiazepines and / or anxiolytics
  • Situations in which patients were not able to complete the questionnaires (altered level of consciousness, visual impairment and / or patients who could not read and / or write)
  • Situations in which the patient requested information about bed bath, previously the beginning of the evaluation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01724762

Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil, 04021-001
Sponsors and Collaborators
Federal University of São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Juliana L Lopes, Ms Federal University of São Paulo
Study Director: Alba LB Barros, PhD Federal University of São Paulo
Study Director: Luiz A Nogueira-Martins Federal University of São Paulo
  More Information

Additional Information:
Publications:
Responsible Party: Juliana de Lima Lopes, Master Degree, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01724762     History of Changes
Other Study ID Numbers: UNIFESP0447
Study First Received: November 6, 2012
Last Updated: November 9, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Baths
Anxiety
Acute Coronary Syndrome
Education, Nursing

Additional relevant MeSH terms:
Anxiety Disorders
Acute Coronary Syndrome
Mental Disorders
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014